Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2011
End Date:October 2014

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A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion
/ (VMT) including macular hole with ocriplasmin.

The present study is designed to assess anatomical and functional outcomes following a
single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic
vitreomacular adhesion (VMA)/ (VMT) including macular hole.

Inclusion Criteria:

- Subjects 18 years of age or older and of either gender

- Presence of vitreomacular adhesion

- Best corrected visual acuity (BCVA) of 20/32 or worse in study eye

- BCVA of 20/800 or better in the non-study eye

Exclusion Criteria:

- History or current evidence of proliferative retinopathy, exudative age-related
macular degeneration (AMD) or retinal vein occlusion in the study eye

- Any vitreous hemorrhage or any other vitreous opacification which precludes the
visualization of the posterior pole by visual inspection OR adequate assessment of
the macula by spectral-domain optical coherence tomography (SD-OCT) in the study eye

- Macular hole of > 400 µm diameter in the study eye

- Presence of epiretinal membrane (ERM)

- Aphakia in the study eye

- High myopia (more than 8D) in study eye

- History of rhegmatogenous retinal detachment in either eye

- History of vitrectomy in the study eye

- Previous participation in this trial or prior administration of ocriplasmin in the
study eye
We found this trial at
25
sites
Portsmouth, New Hampshire 03801
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Portsmouth, NH
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Arlington, Texas 76012
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Arlington, TX
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Austin, Texas 78705
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Austin, TX
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Beverly Hills, California 90211
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Beverly Hills, CA
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Charlotte, North Carolina 28210
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Charlotte, NC
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Cincinnati, Ohio 45242
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Cincinnati, OH
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Cleveland, Ohio 44130
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Cleveland, OH
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Dallas, Texas 75231
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Dallas, TX
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Fort Worth, Texas 76104
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Fort Worth, TX
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Houston, Texas 77030
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Houston, TX
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Huntingdon Valley, Pennsylvania 19006
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Huntingdon Valley, PA
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Kansas City, Missouri 64108
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Kansas City, MO
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McAllen, Texas 78503
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McAllen, TX
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Miami, Florida 33143
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Miami, FL
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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Phoenix, Arizona 85014
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Phoenix, AZ
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Royal Oak, Michigan 48073
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Royal Oak, MI
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Sacramento, California 95819
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Sacramento, CA
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San Antonio, Texas 78240
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San Antonio, TX
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San Francisco, California 94107
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San Francisco, CA
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Syracuse, New York 13224
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Syracuse, NY
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Teaneck, New Jersey 07666
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Teaneck, NJ
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Tyler, Texas 75701
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Tyler, TX
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Walnut Creek, California 94598
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Walnut Creek, CA
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Winter Haven, Florida 33880
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Winter Haven, FL
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